NCT03462719

A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

A Randomized, Open-label, Phase 3 Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Subjects With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL).

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review Committee (IRC).

Conditions

• Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Type	Name	Description
DRUG	Ibrutinib	Participants will receive ibrutinib 420 mg orally once daily up to 15 cycles.
DRUG	Venetoclax	Participants will receive venetoclax in combination with ibrutinib for a total of 12 cycles, beginning at Cycle 4. For the first 5 weeks of venetoclax treatment, the treatment dose will be ramped up from 20 to 400 mg.
DRUG	Chlorambucil	Participants will receive chlorambucil at a dose of 0.5 mg/kg body weight on Days 1 and 15 of Cycles 1 to 6.
DRUG	Obinutuzumab	Participant will receive obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1, and Day 1 of Cycles 2 to 6.
DRUG	Ibrutinib (as Subsequent Therapy)	Participants will receive ibrutinib 420 mg orally once daily until disease progression or unacceptable toxicity during the subsequent therapy phase.

Timeline

• Start date: 2018-04-17
• Primary completion: 2021-02-26
• Completion: 2029-04-05
• First posted: 2018-03-12
• Last updated: 2026-04-13
• Results posted: 2022-03-28

Locations

88 sites across 14 countries: United States, Belgium, Canada, Czechia, Denmark, France, Israel, Netherlands, Poland, Russia, Spain, Sweden, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study